The Recall Desk
ModerateFDA (Drugs)·D-871-2014·Announced 2014-01-29

Fluconazole Tablets Recalled Due to Potential Labeling Errors

Aidapak Services is recalling Fluconazole 200 mg tablets because they may have been mislabeled as Valsartan or Fluconazole 100 mg.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II and involves a labeling error (mislabeling) without reported injuries or illnesses, fitting the criteria for moderate severity.

Plain-English summary

Aidapak Services, LLC is recalling Fluconazole, Tablet, 200 mg (NDC 00172541360) due to a labeling error. The recalled product may have been mislabeled as Valsartan, Tablet, 80 mg (NDC 00078035834) or Fluconazole, Tablet, 100 mg (NDC 68462010230).

The affected repacked drugs were distributed in Arizona, California, Oregon, and Washington. Specific pedigree codes and expiration dates for the potentially mislabeled products are AD65475_10 (EXP: 5/28/2014) and W003064 (EXP: 6/12/2014).

Patients and healthcare providers should verify the labeling of their medications. If a patient has received a product with incorrect labeling, they should contact their healthcare provider or pharmacist for guidance on appropriate action.

The recalled product

Product
FLUCONAZOLE, Tablet, 200 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00172541360.
Affected units
200

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (6)

  • FLUCONAZOLE
  • Tablet
  • 200 mg has the following codes: Pedigree: AD65475_16
  • EXP: 5/28/2014
  • Pedigree: W003065
  • EXP: 6/12/2014.

Distribution

Distributed in 4 states:

Part of a larger recall action

This product is one of 265 recalled by Aidapak Services, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 265 products in this recall →

Same manufacturer · Aidapak Services, LLC

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